Stage III Prostate Cancer AJCC v8 Clinical Trial
— REVELUTIONOfficial title:
Mechanism and Predictors of Cardiotoxicity After Prostate Cancer Treatment: A Parallel Cohort and Randomized Trial Comparing Radiation Alone, Radiation Plus Leuprolide, and Radiation Plus Relugolix
Verified date | May 2024 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase IV clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.
Status | Active, not recruiting |
Enrollment | 93 |
Est. completion date | January 30, 2026 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men >= 18 years old - Non-metastatic prostate cancer - Non-metastatic, biochemically recurrent prostate cancer - Plan to undergo curative-intent pelvic radiation therapy with or without ADT Exclusion Criteria: - Metastatic prostate cancer requiring > 24 months of ADT - Prior exposure to androgen deprivation therapy - Prior exposure to chemotherapy or immunotherapy |
Country | Name | City | State |
---|---|---|---|
United States | Emory Proton Therapy Center | Atlanta | Georgia |
United States | Emory Saint Joseph's Hospital | Atlanta | Georgia |
United States | Emory University Hospital Midtown | Atlanta | Georgia |
United States | Emory University/Winship Cancer Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary plaque volume in major coronary arteries (i.e. left anterior descending, left circumflex, right major coronary arteries) | Using cardiac computed tomography angiography (CCTA), coronary plaque volume will be determined by measuring extent of coronary vessel luminal stenosis on an ordinal scale 0-100% as defined by the Society of Cardiac Computed Tomography. Change in luminal stenosis from baseline to month 12 will be tested using paired tests (Wilcoxon signed rank test or McNemar test). The incidence of moderate-to-severe atherosclerosis (defined as >50% luminal stenosis of a major coronary vessel) at month 12 will be compared between the three treatment groups using Fisher's exact test. Finally, the percent change of maximal stenosis from baseline to month 12 between the three treatment arms will be compared using Kruskal-Wallist test followed by pairwise Wilcoxon signed rank test (P-value adjusted for multiple testing using Holm-Bonferroni method). Multivariable adjustment will be utilized that control for anti-platelet/coagulation and statin use using general logistic regression. | From baseline to 12 months post-treatment initiation | |
Primary | Incidence of high-risk coronary plaque features at month 12 after treatment initiation | Using CCTA, high-risk plaque features, categorized as positive remodeling, low attenuation plaque, and spotty calcium, will be measured at month 0 and month 12 for each treatment arm. Differences in incidence of high-risk plaque features amongst the three treatment arms will be compared using Fisher's exact test. Multivariable adjustment will be utilized that control for anti-platelet/coagulation and statin use using general logistic regression. | From baseline to 12 months post-treatment initiation | |
Primary | Major adverse cardiovascular events | Incidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment. Incidence curves will be estimated by the Kaplan-Meier method and compared between the three treatment arms using a two-sided log-rank test followed by pairwise comparisons with Bonferonni correction. | From baseline to at least 2 years post-treatment initiation | |
Secondary | Acute and late patient-reported morbidity | Adverse events will be assess using patient-reported outcomes (PRO) questionnaires including EPIC-26, IPSS, and SHIM scoring. Assessment will be collected before and at the end of radiotherapy treatment and in follow-up. For each symptom and each domain (i.e. frequency, severity, and interference), counts and frequencies will be provided for the worst score experienced by the patient by treatment arm. The proportion of patients with scores >=1 and >=3 will be compared between groups using a chi-square test (or Fisher's exact test if cell frequencies are <5). | Baseline and month 0, 3, 6, 12, 18, 24 | |
Secondary | Testosterone kinetics | Change in total and free testosterone levels will be measured at baseline and month 0, 3, 6, and 12 between treatment arms. Testosterone change over time will be summarized and plotted over time for each treatment arm. Testosterone levels over time will be assessed using mixed effects regression modeling. | Baseline and month 0, 3, 6, 12 |
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